scope:

This International Standard specifies requirements for a quality management system when an organization:

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

Scope - Supplemental

This document defines quality management system requirements in the rail sector (RQMS):

- applicable throughout the whole supply chain of railway industrial related products for the design and development, manufacturing and maintenance activities (excluding operations and services of rail transports);

- providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain; and

- enhancing and sustaining product quality, including its safety aspects.

NOTE This document allows organizations to have the same flexibility when determining the boundaries and applicability of the quality management system as described in ISO 9001:2015, 4.3.